NCT00463268已完成3 期
Prevention of Postmenopausal Bone Loss in Osteopenic Women With Alendronate Given on a 70 mg Once-every Two Week Regimen: a 2-year, Double-blind, Placebo-controlled Clinical Trial.
University Hospital of Mont-Godinne1 个研究点 分布在 1 个国家目标入组 83 人开始时间: 2007年9月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 83
- 试验地点
- 1
- 主要终点
- percentage of lumbar BMD modification after 2 years
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of the intermittent administration of alendronate in a low dose, 70 mg once every two week, as osteoporosis prevention for menopausal, osteopenic patients, who don't want or can't receive an oestrogenic substitution treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •45 to 60 year-old women
- •Menopausal since at least 6 months
- •Baseline lumbar BMD from -1 till -2.5
排除标准
- •Bone disease other than osteopenia
- •Treatment with selective estrogen receptor modulator (SERMs), calcitonin or hormone replacement therapy within 6 monts prior to randomization
- •Former or current treatment with any bisphosphonate or bone forming agents
- •Chronic use of oral or iv corticosteroids
- •Any diagnosis of malignancy less than 12 months
研究组 & 干预措施
1
Active Comparator
Alendronate 70 mg every 2 weeks
干预措施: alendronate (Drug)
1
Active Comparator
Alendronate 70 mg every 2 weeks
干预措施: Calcium/Vitamin D (Dietary Supplement)
2
Placebo Comparator
Alendronate 70 mg placebo tablet every 2 weeks
干预措施: Calcium/Vitamin D (Dietary Supplement)
2
Placebo Comparator
Alendronate 70 mg placebo tablet every 2 weeks
干预措施: placebo (Drug)
结局指标
主要结局
percentage of lumbar BMD modification after 2 years
时间窗: 2 years
次要结局
- percentage of hip BMD modification (total hip and sub-regions)(2 years)
- percentage of modification of bone remodeling markers(2 years)
研究者
Boutsen Yves
professeur
University Hospital of Mont-Godinne
研究点 (1)
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